Drug reference

Bezafibrate

Fibrate · Antihyperlipidemic

FibrateAntihyperlipidemic

CDSCO approved

EXCRETION

—

not curated

INTERACTIONS

—

none in our sources

PREGNANCY

Manufacturer advises avoid - no information available.

FDA category + note

Mechanism

Bezafibrate is a fibric acid derivative that acts as a peroxisome proliferator-activated receptor (PPAR) activator. Its primary action involves decreasing serum triglyceride levels. It also has a variable effect on LDL-cholesterol.

Indications

Adjunct to diet and other appropriate measures in mixed hyperlipidaemia if statin contra-indicated or not toleratedAdjunct to diet and other appropriate measures in severe hypertriglyceridaemiaMixed hyperlipidaemias (Type III, IV and V)Hypercholesterolaemia (Type II) (inferior to statins and resins)Patients with high TG and low HDL-CH levels

Dosing

Adult: Immediate-release: 200 mg orally three times a day. Modified-release: 400 mg orally once daily. Modified-release dose form is not appropriate in patients with renal impairment.
Renal adjustment: Avoid immediate-release preparations if eGFR less than 15 mL/minute/1.73 m2. Avoid modified-release preparations if eGFR less than 60 mL/minute/1.73 m2. Reduce dose to 400 mg daily if eGFR 40–60 mL/minute/1.73 m2. Reduce dose to 200 mg every 1–2 days if eGFR 15–40 mL/minute/1.73 m2.
Hepatic adjustment: Avoid in significant impairment (except in fatty liver disease).
Geriatric: Dose reduction needed

Contraindications

Gall bladder disease
Hypoalbuminaemia
Nephrotic syndrome
Photosensitivity to fibrates
Significant hepatic impairment (except in fatty liver disease)
eGFR less than 15 mL/minute/1.73 m2 for immediate-release preparations
eGFR less than 60 mL/minute/1.73 m2 for modified-release preparations

Side effects

Common

Appetite decreasedGastrointestinal disorderG.i. upsetMyalgiaRashes

Serious

Acute kidney injury
Cholestasis
Rhabdomyolysis
Cholelithiasis
Depression
Insomnia
Interstitial lung disease
Pancreatitis
Pancytopenia
Paraesthesia
Peripheral neuropathy
Severe cutaneous adverse reactions (SCARs)
Thrombocytopenic purpura

Pregnancy & lactation

Pregnancy

Manufacturer advises avoid - no information available.

Lactation

Manufacturer advises avoid - no information available.

Drug interactions

Alirocumab

Moderate

Textbook

Reduced risk of rhabdomyolysis compared to other fibrate-statin combinations, but vigilance for myopathy is still advised due to class effect.

This combination is generally considered safer than statin-gemfibrozil, but practitioners should still exercise caution and monitor for muscle symptoms.

Source: KDT 7e · p639

Atorvastatin + Aspirin

Moderate

Textbook

Reduced risk of rhabdomyolysis compared to other fibrate-statin combinations, but vigilance for myopathy is still advised due to class effect.

This combination is generally considered safer than statin-gemfibrozil, but practitioners should still exercise caution and monitor for muscle symptoms.

Source: KDT 7e · p639

Atorvastatin

Moderate

Textbook

Reduced risk of rhabdomyolysis compared to other fibrate-statin combinations, but vigilance for myopathy is still advised due to class effect.

This combination is generally considered safer than statin-gemfibrozil, but practitioners should still exercise caution and monitor for muscle symptoms.

Source: KDT 7e · p639

Evolocumab

Moderate

Textbook

Reduced risk of rhabdomyolysis compared to other fibrate-statin combinations, but vigilance for myopathy is still advised due to class effect.

This combination is generally considered safer than statin-gemfibrozil, but practitioners should still exercise caution and monitor for muscle symptoms.

Source: KDT 7e · p639

Ezetimibe

Moderate

Textbook

Reduced risk of rhabdomyolysis compared to other fibrate-statin combinations, but vigilance for myopathy is still advised due to class effect.

This combination is generally considered safer than statin-gemfibrozil, but practitioners should still exercise caution and monitor for muscle symptoms.

Source: KDT 7e · p639

Fluvastatin

Moderate

Textbook

Reduced risk of rhabdomyolysis compared to other fibrate-statin combinations, but vigilance for myopathy is still advised due to class effect.

This combination is generally considered safer than statin-gemfibrozil, but practitioners should still exercise caution and monitor for muscle symptoms.

Source: KDT 7e · p639

Lomitapide

Moderate

Textbook

Reduced risk of rhabdomyolysis compared to other fibrate-statin combinations, but vigilance for myopathy is still advised due to class effect.

This combination is generally considered safer than statin-gemfibrozil, but practitioners should still exercise caution and monitor for muscle symptoms.

Source: KDT 7e · p639

Lovastatin

Moderate

Textbook

Reduced risk of rhabdomyolysis compared to other fibrate-statin combinations, but vigilance for myopathy is still advised due to class effect.

This combination is generally considered safer than statin-gemfibrozil, but practitioners should still exercise caution and monitor for muscle symptoms.

Source: KDT 7e · p639

Mevastatin

Moderate

Textbook

Reduced risk of rhabdomyolysis compared to other fibrate-statin combinations, but vigilance for myopathy is still advised due to class effect.

This combination is generally considered safer than statin-gemfibrozil, but practitioners should still exercise caution and monitor for muscle symptoms.

Source: KDT 7e · p639

Nicotinic Acid

Moderate

Textbook

Reduced risk of rhabdomyolysis compared to other fibrate-statin combinations, but vigilance for myopathy is still advised due to class effect.

This combination is generally considered safer than statin-gemfibrozil, but practitioners should still exercise caution and monitor for muscle symptoms.

Source: KDT 7e · p639

Oral Anticoagulants

Moderate

Textbook

Enhanced action of oral anticoagulants, increasing the risk of bleeding.

Close monitoring of coagulation parameters (e.g., INR) is necessary when initiating or adjusting bezafibrate in patients on oral anticoagulants.

Source: KDT 7e · p639

Orlistat

Moderate

Textbook

Reduced risk of rhabdomyolysis compared to other fibrate-statin combinations, but vigilance for myopathy is still advised due to class effect.

This combination is generally considered safer than statin-gemfibrozil, but practitioners should still exercise caution and monitor for muscle symptoms.

Source: KDT 7e · p639